May 20, 2012 1

SeeLens

Clinical Evaluation

The microsurgery of the eye convention In memory of Prof. Blumenthal

Eilat,2009

By:

Prof. Hanna Garzozi Bnei-Zion MC

SeeLens

The SeeLens has a CE mark since December 2006.

More than 10,000 SeeLens Intraocular lenses were sold across Europe and the rest of the world until October 2008.

Excellent reviews and feedbacks were received by surgeons and distributors in all countries where the SeeLens was implanted.

Background

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SeeLens

The SeeLens was registered for sell in Israel on May 2008 with no limitations.

Background

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Specifications SeeLens

Optic Diameter 6.0 mm

Overall diameter 13.0 mm

Power range +1.0D to +40.0D

(7.0D to 31.0D increments of 0.5D)

Optic design Spherical equi-convex

Lens design Double square edge with 360 º

stepped barrier

Haptic angulation 5º

Material Hydrophilic Acrylic – HEMA/EOEMA

UV Blocker

Refractive index 1.462 (35º c)

YAG laser Compatible

A constant 118.6

Placement Capsular bag or Sulcus

Injection – incision size 2.5 mm Incision

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Square edge Design SeeLens

The SeeLens has a

unique 3600 double

square edge

In order to prevent

Posterior Chamaber

Opacification

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Haptic Design SeeLens

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The SeeLens holds a special

designed C-loop providing:

Excellent stability in the capsular bag

Endurance to tilt & decentration.

Wide angle of contact with the capsular

bag.

Haptic Design SeeLens

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The SeeLens Haptic design has passed all the tests required by the

ISO11979-3 tests.

The tests were conducted by the most distinguished and strict

ophthalmic medical device test laboratory of MDT GMBH. (I.E. Compression force, Axial length displacement , Decentration, Tilt, Angle of contact, etc.)

SeeLens SeeLens Evaluation

Site Surgeon # of patients

Ein-Tal, Israel Prof. Ehud Assia 30

Bnei-Zion, Israel Prof. Hana Garzuzi 33

Assuta P-T, Israel Dr. Dan Zaksh 20

Pradubice, Czech Prof. Jan Novak 50

Total number of patients: 133

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A non-randomized, open,

prospective, multicenter study

was conducted.

SeeLens SeeLens Evaluation

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Patients follow up:

1) Pre operative examination

2) 1 day postoperatively

3) 7-10 days postoperatively

4) 1 month postoperatively

5) 3 months postoperatively.

6) 1 year postoperatively*.

7) 2 year postoperatively.

*1 year follow up started on November 2008.

SeeLens SeeLens Evaluation

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Post operative tests:

Uncorrected &Best-corrected visual acuity (except for day 1)

Refraction.

Intraocular pressure.

Slit lamp examination (The same tests performed preoperatively)

IOL location and centration.

Records of complication and Adverse Events

Extent of PCO

SeeLens Clinical

Evaluation

Eligibility criteria

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INCLUSION CRITERIA

•Age > 50 years

•Senile cataract

•Refractive cylinder < -1.5 diopter

•Planed surgery technique: cataract extraction by ECCE Phacoemolsification.

•IOL power, calculated by biometry measurements by IOLMASTER, will be in the range

of 15 - 25.

SeeLens Clinical

Evaluation

Eligibility criteria

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EXCLUSION CRITERIA •Allergy or intolerance to required study medications (including antibiotic).

•Amblyopia.

•History or evidence of any Ocular disease that may effect Visual Acuity

(i.e.: Uncontrolled glaucoma, Ocular injury, Corneal pathologies, Retinal pathologies in

general and macular pathologies in particular, diabetic Retinopathy, Uveitis, Aniridia or

iris atrophy, Vitreous pathologies (patients with vitreous separation or floaters can be

included).

•Rubella cataract.

•Any other ocular condition that may predispose a subject to future complications or

contraindicate implantation of the model SEELENS

•Previous ocular surgery, including refraction surgery (study eye).

•Microphthalmos.

•Extreme axial length (outside the range of 21.5 – 25).

•Surgical complication (not IOL related), that may effects study results (i.e.

Capsular tear or rupture during cataract extraction).

•Posterior Capsule scar or opacification if demonstrated during the cataract

extraction surgery.

•Multiple operative procedures during cataract extraction.

SeeLens Clinical

Evaluation

ISO standards

The ISO Standard:

Requirements defined by ISO 11979-7 2001.

1. Post Operative BCVA of at least 6/12 (20/40)

within 88% of patients' population.

2. IOL related Post Operative complication and

Adverse Events equal to or less then the allowed

rate defined by ISO 11979-7 2001.

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SeeLens Clinical

Evaluation

Evaluation Key Parameters

Success criteria for the study were chosen

according to the ISO standards .

More efficacy Hanita Lenses .

The key efficacy parameters are:

Best Corrected Visual Acuity (BCVA)

Predictability of refractive correction

The key safety parameters include:

IOL behavior during implantation and follow-up

IOL related infection and/or inflammatory reactions

Posterior Capsular Opacification (PCO). May 20, 2012 14

SeeLens Clinical

Evaluation

3month follow up

The post operative statistics was performed

on the 3 month follow up.

Paired T-test was done on the post op 1 day

1 week, 1 month, 3 month surveys.

ANOVA (Analysis of Variance) was done to

the different groups of surgeons in order to

determine the parameters that might be

affiliated to the surgeon style and technique on

the lens performance.

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SeeLens Clinical

Evaluation Preoperative General Data

Age: 71±8, range- 51~90

Gender: female 77 (57.9%) male 56 (42.1%)

Eye: left 67 (50.4%) right 66 (49.6%)

Ocular disease: 20 (15%)

i.e: hypermetropia, glaucoma, IFIS, AMD.

Pseudoexfoliation:

scaled from 0(no PXF)- 4 (hard PXF)

Systemic disease: 84 (63.2%)

mostly hypertension and heart problem

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PXF Scale 0 1 2 3 4

Sum percent

123 92.5%

2 1.5%

7 5.3%

1 0.8%

0 0%

SeeLens Clinical

Evaluation Implantation Behavior Scale : 0(Excellent performance)-4(poor performance)

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SeeLens Clinical

Evaluation Tilt & Decentration

Scale : 0(Excellent performance)-4(poor performance)

All surgeons scaled the Tilt and Decentration on a 0-4 scale.

All of the lenses were reported to have ZERO Decentration & Tilt

Typical Pentacam image of the SeeLens position.

by Prof. Novak

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SeeLens Clinical

Evaluation BCVA

Very good visual acuity obtained post operatively.

This rise (mean±SD: 0.49±0.04) was found to be highly significant (Paired

samples t-test, p

SeeLens Clinical

Evaluation BCVA

ISO Compliance

ISO standard required to have 88% of the patients above the 6/12 BCVA

The SeeLens achieved 100% of the patients above the 6/12 BCVA for all patients

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Mean BCVA:

0.93±0.12

SeeLens Clinical

Evaluation BCVA- ANOVA

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ANOVA tests between the surgeons were made – finding that:

Differences between 2 surgeons for BCVA Pre Op were

significantly different – surgeon 1&4.

The significant difference between the groups has remained

also in the post op values.

0

0.2

0.4

0.6

0.8

1

1 2 3 4

Preop 0.5 0.333 0.451 0.407

post op 0.996 0.857 0.926 0.846

VA

(D

eci

mal

)

Pre &Post op mean BCVA per surgeon

SeeLens Clinical

Evaluation Diopter Shift

The diopter shift deviates around the center.

All refraction calculations were conducted using an estimated A-constant of

118.6 in the Zeiss IOLMaster SRK/T formulation.

The mean targeted refraction difference (diopter shift) is -0.14D

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SeeLens Clinical

Evaluation Diopter Shift

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The extreme values outside the range of (+1)~(-1) occurred mainly in

one surgeon with very low targeted refraction the rest show low SNR in

the IOLMASTER reading

From the OSN quoting a study in sweeden of 23,244 eyes: J Cataract Refract Surg. 2008;34(11):1935-1939.

“19,489 patients (83.8%) were within ±1 D of the difference between targeted refraction

and postop refraction.”

In the SeeLens study 84.2% of the patients were within the middle ±1

diopter shift range.

http://www.osnsupersite.com/view.aspx?rid=32476

SeeLens Clinical

Evaluation Operative and measured data

Axial length: 23.45±0.85[mm], range 21.69[mm]~25.83[mm]

Averaged K reading K=44.1±1.4 [D] ranged 40.47[D] ~47.21[D]

Mean diopter power used in the operations: 21.12±2.03D, range15D to 25D

Mean incision size before implantation: 2.62±0.42 mm

Mean incision size after implantation: 2.68±0.32 mm

Mean post op spherical equivalence was calculated to be : -0.519D

Targeted refraction: -0.4±0.464[D] ranged +0.2[D]~ -3.0[D]

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SeeLens Clinical

Evaluation Intraocular Pressure

As can be noticed 100% of the eyes IOP remained within the normal

range of IOP with in population.

No high intra ocular pressure was induced to the eye after the

implantation with the SeeLens IOL

Pre-operative IOP was 14.98±2.61 mmHg,

Post –operative IOP was 13.18±2.66 mmHg. This decrease (mean±SD: 1.89±2.95 mmHg) was found to be statistically significant

(Paired samples t-test, p

SeeLens Clinical

Evaluation Damage to IOL

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Undamaged

haptic

optic

96.25%

1.5%

2.25%

Out of 133 implantations 5 damages to IOL occurred:

2 scratches on the periphery of the optic – IOLs not replaced, no complaint from patient.

2 scratches occurred on the haptic- IOLs were not replaced, lens stable in the capsule.

1 haptic tore because of bad placement in the cartridge- lens was replaced.

SeeLens Clinical

Evaluation

Postoperative complications, such as irritated Conjuctiva, flared anterior

chamber, Corneal Edema, etc., were noted and reported by the

surgeons, as requested by the protocol.

There was no evidence of post operative infection or excessive

inflammation in any of the patients.

Postoperative complication

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SeeLens Clinical

Evaluation Conclusions – 3 month FU

BCVA All patients achieved above 6/12 BCVA

70% achieved 6/6 vision,

Predictability

Diopter shift is well centered around the zero value.

50% of the patients were corrected to their targeted refraction.

It is clear that the A-constant value is stable on118.6.

Behavior during implatation

On a scale of 0-4 the lens was rated between 0 to 1 at all parameters

Infection or inflammatory reaction

No infection or inflammatory reaction was reported.

PCO

Until now no case of PCO was recorded.

Will be investigated in the 1&2 year follow up.

1 year follow up has started on November 2008.

Compliance to ISO standard

The SeeLens evaluation results until now

completely comply to the ISO 11979-7 2001

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SeeLens

Clinical Evaluation

SeeLens Clinical

Evaluation

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